HIVPhase 2NCT02415985
Pharmacokinetics and Safety of Rifabutin 150 mg Once Daily Versus Rifabutin 300 mg Thrice Weekly
A Phase 2 study testing Lopinavir/r will be supplied by NHSO/GPO and Rifabutin in people with HIV and Tuberculosis, run by The HIV Netherlands Australia Thailand Research Collaboration at 4 sites in Thailand.
Trial summary
To describe the pharmacokinetics of rifabutin 150 mg once daily versus rifabutin 300 mg thrice weekly in combination with LPV/r 400/100mg based HAART in HIV/TB infected patients Read more about this study
- Who is it for?
- Ages 18 to 60 years
- Conditions the study is for
- HIV, Tuberculosis
- What is being tested?
- Lopinavir/r will be supplied by NHSO/GPO and Rifabutin
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 40 participants
- Where
- 4 sitesThailand
- Study dates
- Jun 2015to Dec 2019
- Phase
- Phase 2
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 60 years
- All sexes
- No healthy volunteers
- Adult
Who may be able to join
- Confirmed HIV positive after voluntary counseling and testing
- Aged >18-60years of age
- PI-naïve (NNRTI intolerance/failure) or PI experience ( TB developed during on salvage regimen) without prior PI mutation
- Any CD4 cell count
- ALT <5 times ULN
- Serum creatinine <1.4 mg/dl
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- Hemaglobin >7 mg/L
- TB is diagnosed and planned to receive stable doses of rifabutin containing anti-TB therapy for at least another 4 week period after initiation of ART
- No other active OI (CDC class C event), except oral candidiasis or disseminated MAC
- Body weight >40kg
- Able to provide written informed consent
Who cannot join
- Current use of steroid (except short course steroid for IRIS) and other immunosuppressive agents.
- Current use of any prohibited medications related to drug pharmacokinetics.
- Patients with current alcohol or illicit substance use that in the opinion of the site Principal Investigator would conflict with any aspect of the conduct of the trial.
- Unlikely to be able to remain in follow-up for the protocol defined period.
- Patients with proven or suspected acute hepatitis. Patients with chronic viral hepatitis are eligible provided ALT, AST < 5 x ULN.
- Karnofsky performance score <30%
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- TB meningitis and bone/joints ( due to longer period of anti TB drug)
- Pregnancy
- Patient choose to use efavirenz, not LPV/r. However, in ART naïve, EFV is allowed after intensive PK of LPV/r and rifabutin at week 2-4.
Trial locations and contacts
4 sites in 1 country.
Thailand4 sites
Chest Division, Faculty of Medicine, Chulalongkorn University
Bangkok, 10330
HIV-NAT, Thai Red Cross - AIDS Research Centre
Bangkok, 10330
Infectious Diseases, Faculty of Medicine, Chulalongkorn University
Bangkok, 10330
Bamrasnaradura Infectious Diseases Institute
Nonthaburi, 11000
About this study
Official title: A Pilot Study of the Pharmacokinetics and Safety of Rifabutin 150 mg Once Daily Versus Rifabutin 300 mg Thrice Weekly With Lopinavir/Ritonavir Based HAART in HIV/TB Co-infected Patients
To describe the pharmacokinetics of rifabutin 150 mg once daily versus rifabutin 300 mg thrice weekly in combination with LPV/r 400/100mg based HAART in HIV/TB infected patients
Read the detailed description
The overall aim of the project is to evaluate rifabutin as a replacement for rifampicin, for the combined treatment of tuberculosis and HIV infection. Rifabutin represents an alternative to rifampicin for HIV infected patients as its half-life is longer and the enzymatic induction effect appears to be less important on the associated ART drugs. This phase II trial is to determine precisely the pharmacokinetics parameters of rifabutin in combination with LPV/r regimens in Thai HIV/TB infected patients, in order to define optimal doses that will be further tested in a larger phase III trial comparing safety, tolerability and efficacy of rifabutin and rifampicin regimens.
- Conditions
- HIV, Tuberculosis
- Being tested
- Lopinavir/r will be supplied by NHSO/GPO, Rifabutin
- Keywords
- pharmacokinetics of rifabutin, HIV/TB co-infection, resource limited setting, AUC, Cmax, Cmin, Ctrough
- Medical subject headings
- Tuberculosis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Lopinavir/r will be supplied by NHSO/GPODrug
Also called LPV/rtv
200/50 mg tablet LPV/rtv
RifabutinDrug
| Study group | Role | What they receive |
|---|---|---|
| rifabutin 150 | Other | rifabutin 150 mg (1 capsule) once daily Receives: Drug: Lopinavir/r will be supplied by NHSO/GPO; Drug: Rifabutin |
| rifabutin 300 | Other | rifabutin 150 mg (2 capsules) 300 mg 3 times a week Receives: Drug: Lopinavir/r will be supplied by NHSO/GPO; Drug: Rifabutin |
What is being measured
The primary outcome is the main question the study is designed to answer.
pharmacokinetics of rifabutin Cmax
Cmax The peak plasma concentration of rifabutin after administration
Measured: 48 weeks
Secondary outcomes (14)
adverse events
number of participants with adverse events
Measured: 48 weeks
viral load
Measured: 48 weeks
CD4
mean CD4 rise from baseline
Measured: 48 weeks
Monodrug resistant TB
Measured: 48 weeks
death
Measured: 48 weeks
AIDS event
Measured: 48 weeks
TB cure
Measured: 48 weeks
TB relapse
Measured: 48 weeks
Multidrug-resistant TB (MDR TB)
Measured: 48 weeks
TB treatment failure
Measured: 48 weeks
Extensively drug resistant TB (XDR TB)
Measured: 48 weeks
weight gain
change from baseline in weight gain at 48 weeks
Measured: 48 weeks
defervescence
change from baseline in defervescence at 48 weeks
Measured: 48 weeks
Karnofsky score
change from baseline in Karnofsky score at 48 weeks
Measured: 48 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted14 Apr 2015 (estimated)
- Study startJun 2015
- Primary completionDec 2019
- Study completionDec 2019
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for HIVStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 2
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 40 participants (actual)
Sponsor and investigators
- Lead sponsor
- The HIV Netherlands Australia Thailand Research Collaboration
- Sponsor type
- University, hospital or other
- Collaborators
- Bamrasnaradura Infectious Diseases Institute, Chulalongkorn University
- Responsible party
- Sponsor
- Investigators
- Anchalee Avihingsanon, MD, PhD, Principal investigator, Thai Red Cross AIDS Research Centre
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02415985
- Sponsor's protocol ID
- HIV-NAT 116
- Status last verified
- Feb 2020
- First submitted
- 1 Apr 2015
- Last updated
- 12 Feb 2020
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 12 Feb 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Pilot Study of the Pharmacokinetics and Safety of Rifabutin 150 mg Once Daily Versus Rifabutin 300 mg Thrice Weekly With Lopinavir/Ritonavir Based HAART in HIV/TB Co-infected Patients
- ClinicalTrials.gov ID
- NCT02415985
- Acronym / sponsor ID
- HIV-NAT 116
- Conditions
- HIV, Tuberculosis
- Keywords
- pharmacokinetics of rifabutin, HIV/TB co-infection, resource limited setting, AUC, Cmax, Cmin, Ctrough
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 40 participants (actual)
- Lead sponsor
- The HIV Netherlands Australia Thailand Research CollaborationUniversity, hospital or other
- Collaborators
- Bamrasnaradura Infectious Diseases Institute, Chulalongkorn University
- Study start
- Jun 2015 (actual)
- Primary completion
- Dec 2019 (actual)
- Study completion
- Dec 2019 (actual)
- First posted
- 14 Apr 2015 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
To describe the pharmacokinetics of rifabutin 150 mg once daily versus rifabutin 300 mg thrice weekly in combination with LPV/r 400/100mg based HAART in HIV/TB infected patients
Detailed description
The overall aim of the project is to evaluate rifabutin as a replacement for rifampicin, for the combined treatment of tuberculosis and HIV infection. Rifabutin represents an alternative to rifampicin for HIV infected patients as its half-life is longer and the enzymatic induction effect appears to be less important on the associated ART drugs. This phase II trial is to determine precisely the pharmacokinetics parameters of rifabutin in combination with LPV/r regimens in Thai HIV/TB infected patients, in order to define optimal doses that will be further tested in a larger phase III trial comparing safety, tolerability and efficacy of rifabutin and rifampicin regimens.
Study design
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| rifabutin 150 | Other | Drug: Lopinavir/r will be supplied by NHSO/GPO, Drug: Rifabutinrifabutin 150 mg (1 capsule) once daily |
| rifabutin 300 | Other | Drug: Lopinavir/r will be supplied by NHSO/GPO, Drug: Rifabutinrifabutin 150 mg (2 capsules) 300 mg 3 times a week |
Who may qualify
- Ages
- 18 to 60 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (11 listed)
- Confirmed HIV positive after voluntary counseling and testing
- Aged >18-60years of age
- PI-naïve (NNRTI intolerance/failure) or PI experience ( TB developed during on salvage regimen) without prior PI mutation
- Any CD4 cell count
- ALT <5 times ULN
Key exclusion criteria (9 listed)
- Current use of steroid (except short course steroid for IRIS) and other immunosuppressive agents.
- Current use of any prohibited medications related to drug pharmacokinetics.
- Patients with current alcohol or illicit substance use that in the opinion of the site Principal Investigator would conflict with any aspect of the conduct of the trial.
- Unlikely to be able to remain in follow-up for the protocol defined period.
- Patients with proven or suspected acute hepatitis. Patients with chronic viral hepatitis are eligible provided ALT, AST < 5 x ULN.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Lopinavir/r will be supplied by NHSO/GPOAlso: LPV/rtv200/50 mg tablet LPV/rtv | Drug | rifabutin 150, rifabutin 300 |
| Rifabutin | Drug | rifabutin 150, rifabutin 300 |
Primary outcome
pharmacokinetics of rifabutin Cmax
Time frame: 48 weeks
Cmax The peak plasma concentration of rifabutin after administration
14 secondary outcomes
adverse events
Time frame: 48 weeks
viral load
Time frame: 48 weeks
CD4
Time frame: 48 weeks
Monodrug resistant TB
Time frame: 48 weeks
death
Time frame: 48 weeks
AIDS event
Time frame: 48 weeks
TB cure
Time frame: 48 weeks
TB relapse
Time frame: 48 weeks
Multidrug-resistant TB (MDR TB)
Time frame: 48 weeks
TB treatment failure
Time frame: 48 weeks
Extensively drug resistant TB (XDR TB)
Time frame: 48 weeks
weight gain
Time frame: 48 weeks
defervescence
Time frame: 48 weeks
Karnofsky score
Time frame: 48 weeks
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 12 Feb 2020.
- HIV Netherlands Australia Thailand Research CollaborationLink provided by the sponsor.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Anchalee Avihingsanon, MD, PhD principal investigator
Thai Red Cross AIDS Research Centre
4 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing Lopinavir/r will be supplied by NHSO/GPO and Rifabutin in people with HIV and Tuberculosis, run by The HIV Netherlands Australia Thailand Research Collaboration at 4 sites in Thailand.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 11 inclusion and 9 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 12 Feb 2020. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 4 sites in Thailand. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
pharmacokinetics of rifabutin Cmax (time frame: 48 weeks). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 12 Feb 2020.